Recall Z-2642-2010 ยท GCJ Laparoscope, General & Plastic Surgery
Olympus America Inc.
Camera Head OTV-S7H-1D-L08E and Camera Head OTV-S7H-1D-F08E (designed to be used with Olympus endoscopic equipment)
| Date | Oct 1, 2010 (initiated Aug 20, 2010) |
| Status | Terminated |
| Reason | Mislabeled. Endoscopic body-type camera heads labeled as cardiac-type. |
| Root cause | Labeling mix-ups |
| Action | Asked consignees to return camera heads to correct the labeling. |
| Quantity | 217 camera heads |
| Distribution | nationwide; camera heads were serviced and returned to consignees in March 2003 - September 2007 timeframe |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.